Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect
Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect that may cause a drop in ECMO circuit blood flow, a significant injury risk, which aligns with the criteria for a Severe (Score 4) classification.
Plain-English summary
Datascope Corporation is recalling seven units of the BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02. The affected units are identified by Lot 3000061507. These devices were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington.
The recall is due to a defect in the Better Bladder device included in the kits. A seal separation from the housing may allow air to enter the housing and collapse the balloon. This failure may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Healthcare facilities and consumers who possess these specific custom tubing kits should stop using them and contact Datascope Corporation for instructions on return or replacement.
The recalled product
- Product
- BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — ECMO Tubing
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 3000061507
Distribution
Part of a larger recall action
This product is one of 28 recalled by Datascope Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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